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NCT03441360 · OUTCOME

Number of Participants With Shift From Baseline to Worst Post-baseline for Karnofsky Performance Status Scores

Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS) · Source last updated 2022-10-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 32 months

What was measured

Karnofsky performance status assessed as best and worst score change from baseline using Karnofsky performance criteria.Score classified participants based on functional impairment. Ranges from 0-100, lower score, worst survival for most serious illnesses, 100=normal;no complaints;no evidence of disease;90=able to carry on normal activity with effort,minor sign or symptoms of disease;80=normal activity with effort;some sign or symptoms of disease;70= cares for self;unable to carry on normal activity or do active work;60=requires occasional assistance,but able to care for most personal needs;50=requires considerable assistance;frequent medical care;40=disabled;requires special care; assistance;30=severely disabled;hospitalization indicated,although death is not imminent;20=very sick;hospitalization; 10=moribund;fatal processes progressively worsening;0=dead.Data for this endpoint was collected;analyzed up to PCD. As no further data collected, therefore data is reported till PCD only.

Analysis population: The safety analysis set included all participants who receive at least 1 dose of study drug. Here overall number analyzed "N" are the participants who were evaluable for the outcome measure for the outcome measure with non-missing data at both baseline and any post-baseline timepoint.

Groups in this outcome

Eribulin Mesylate 1.4 mg/m^2: RMS

Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

Eribulin Mesylate 1.4 mg/m^2: NRSTS

Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

Eribulin Mesylate 1.4 mg/m^2: EWS

Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eribulin Mesylate 1.4 mg/m^2: RMS1
Eribulin Mesylate 1.4 mg/m^2: NRSTS0
Eribulin Mesylate 1.4 mg/m^2: EWS1

Reported measurements

Baseline score 70 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS1Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 50
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 60
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 70
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 80
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 90
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 90 to worst post-baseline score 50
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 90 to worst post-baseline score 60
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 90 to worst post-baseline score 70
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Baseline score 90 to worst post-baseline score 80
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 90 to worst post-baseline score 90
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 90 to worst post-baseline score 100
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Karnofsky performance status assessed as best and worst score change from baseline using Karnofsky performance criteria.Score classified participants based on functional impairment. Ranges from 0-100, lower score, worst survival for most serious illnesses, 100=normal;no complaints;no evidence of disease;90=able to carry on normal activity with effort,minor sign or symptoms of disease;80=normal activity with effort;some sign or symptoms of disease;70= cares for self;unable to carry on normal activity or do active work;60=requires occasional assistance,but able to care for most personal needs;50=requires considerable assistance;frequent medical care;40=disabled;requires special care; assistance;30=severely disabled;hospitalization indicated,although death is not imminent;20=very sick;hospitalization; 10=moribund;fatal processes progressively worsening;0=dead.Data for this endpoint was collected;analyzed up to PCD. As no further data collected, therefore data is reported till PCD only.
groups
  1. description
    Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    OG000
    title
    Eribulin Mesylate 1.4 mg/m^2: RMS
  2. description
    Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    OG001
    title
    Eribulin Mesylate 1.4 mg/m^2: NRSTS
  3. description
    Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    OG002
    title
    Eribulin Mesylate 1.4 mg/m^2: EWS
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all participants who receive at least 1 dose of study drug. Here overall number analyzed "N" are the participants who were evaluable for the outcome measure for the outcome measure with non-missing data at both baseline and any post-baseline timepoint.
reporting Status
POSTED
time Frame
Baseline up to approximately 32 months
title
Number of Participants With Shift From Baseline to Worst Post-baseline for Karnofsky Performance Status Scores
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice